A Study of Below The Knee Arteries' Stenosis or Occlusion Treated With LEGFLOW OTW

Peripheral Artery Disease Clinical Trial

Official title:

Evaluation the Safety and Efficacy of the Paclitaxel Releasing Peripheral Balloon Dilatation Catheter （LEGFLOW）in Treatment of Stenosis or Occlusion in Below The Knee Arteries: A Prospective, Multicenter, Randomized, Controlled Clinical Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02962232
• Other study ID #: LEGFLOW-2015-02
• Status: Recruiting
• Phase: N/A
• Start date: November 2016
• Est. completion date: December 2020

Study information

• Verified date: November 2018
• Source: ZhuHai Cardionovum Medical Device Co., Ltd.
• Contact: Chen zhong, professor
• Email: chenzhong8658[@]vip.sina.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To evaluate the safety and efficacy of the Paclitaxel Releasing Peripheral Balloon Dilatation Catheter (LEGFLOW) compared to the PTA catheter (AMPHIRION DEEP) in treatment of stenosis or occlusion in below the knee artery.

Description:

To evaluate the safety and efficacy of the Paclitaxel Releasing Peripheral Balloon Dilatation Catheter (LEGFLOW) compared to the PTA catheter (AMPHIRION DEEP) in treatment of stenosis or occlusion inbelow the knee artery.

This is a prospective, multi-center, randomized, control, opening, superiority designed clinical study. Plan to enroll 172 eligible subjects in 15 centers in China, all these subjects will be randomized 1:1 to the study group (LEGFLOW OTW group, n=86) and control group (AMPHIRION DEEP group, n=86), and accept the treatment of LEGFLOW OTW and AMPHIRION DEEP respectively.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 172
• Est. completion date: December 2020
• Est. primary completion date: June 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

Inclusion Criteria:

• age from 18 to 85 years (include 18 and 85 year);

• critical limb ischemia subjects (Rutherford classification from 3 to 6)

• expective survival more than 1 year;

• can understand the study objective, self willing enrolls and sign the informed consent, and accept scheduled followed up at the specific time.

Angiographic inclusive criteria:

• reference vessel diameter 2.0-3.5mm;

• stenosis or occlusion in arterial vasculature below the knee shall have distal outflow;

• target lesion stenosis =70% or occlusion, length =270mm;

• if subject has ipsilateral / contralateral iliac lesions, the iliac lesion shall meet all the following criteria:

• iliac lesion or occlusion length =100mm and

• shall be treated earlier than the target lesion and

• shall be treated successfully. the successful treatment standard: 1) residual stenosis <30%; 2) without flow limiting dissection 3) without thrombosis, embolism or any other serious adverse events

Exclusion Criteria:

• subjects currently participate in other drugs or medical devices clinical study and have not reach the primary endpoint;

• childbearing aged women whose pregnancy test before intervention operation is not negative, and lactating mothers;

• subjects with renal function insufficiency (serum creatinine> 2.5mg / dL or in renal dialysis);

• subjects have known be allergy or contraindication to the contrast agent, paclitaxel, heparin, antiplatelet, anticoagulant or thrombolytic agents;

• subjects plan to a major amputation (over metatarsal level);

• stroke subjects within 3 months or stroke subjects with severe hemiplegia and aphasia associated sequelaes over 3 months before the intervention operation;

• subjects with acute myocardial infarction, thrombolytic therapy or angina within 30 days before the intervention operation;

• subjects whose target lesion limb have gangrene (the gangrene range over the metatarsophalangeal joint);

• target lesion is a stenosis or occlusion that have prior been treated by scaffold implantation, DEB, ordinary balloon catheter or bypass graft;

• lesions and /or occlusion locate or extend to popliteal artery or below ankle joint;

• subjects requiring be intervention in bilateral lower limb;

• the stenosis lesion of ipsilateral femoral artery or ipsilateral popliteal artery have a diameter stenosis =50% untreated before the intervention operation;

• ipsilateral femoral artery or ipsilateral popliteal artery has single or adjacent lesion length =15cm, or ipsilateral femoral artery or ipsilateral popliteal artery has multiple lesion and one of these multiple lesion length =10cm or occlusion;

• - adjacent lesion: 1) interval no more than 30 mm, 2) can be treated as a single lesion;

• - multiple lesion: 1) interval no more than 30 mm, 2) need to be treated as multiple lesion;

• the residual stenosis still =30%, even when the length <15cm and stenosis =50% single or adjacent lesion in ipsilateral femoral artery or ipsilateral popliteal artery has been treated, or when each lesion length <10cm and stenosis =50% multiple lesion in ipsilateral femoral artery or ipsilateral popliteal artery has been treated;

• DES and /or DEB has been used in the inflow vessel of lesions treatment;

• subject has no patency vessel below the ankle artery before the intervention operation;

• target vessel aneurysm;

• acute or subacute thrombosis in target vessel;

• angiography shows severe calcification in the target lesion (before contrast injection or digital subtraction angiography, intensive annular calcifications that make target lesion not expansion and / or a calcification within the target lesion and locate on either sides of the vessel wall whose continuous length over than 5cm);

• lesions that the guild wire cannot pass through;

• subjects need be treated by thrombus endarterectomy, percutaneous transluminal plaque circumcision or laser treatment device indicate by intraoperative angiography;

Related Conditions & MeSH terms

• Peripheral Arterial Disease
• Peripheral Artery Disease

Intervention

Device:
• Paclitaxel Releasing Peripheral Balloon Dilatation Catheter
treatment group
• PTA catheter
control group

Locations

Country	Name	City	State
China	Beijing Anzhen Hospital Capital Medical University	Beijing
China	Beijing Chao-Yang Hospital	Beijing
China	Beijing Frendship Hospital, Capital Medical University	Beijing
China	Beijing Hospital	Beijing
China	Beijing Shijitan Hospital, Capital Medical University	Beijing
China	Chinese PLA General Hospital	Beijing
China	Fuwai Hospital, Chinese Accadamy of Medical Sciences	Beijing
China	Xiangya Hospital Central South University	Changsha	Hunan
China	West China Hospital, Sichuan University	Chengdu	Sichuan
China	The First Affiliated Hospital of Fujian Medical University	Fuzhou	Fujian
China	Hainan General Hospital	Haikou	Hainan
China	The Second Affiliated Hospital of Nanchang University	Nanchang	Jiangxi
China	Jiangsu Province Hospital	Nanjing	Jiangsu
China	Renji Hospital Shanghai Jiaotong University School of Medicine	Shanghai
China	Shanghai Ninth people's Hospital, Shanghai Jiaotong University School of Medicine	Shanghai
China	Hebei General Hospital	Shijiazhuang	Hebei
China	The First Hospital of Hebei Medical University	Shijiazhuang	Hebei
China	Tianjing Medical University General Hospital	Tianjin
China	The First Affiliated Hospital of Xi'an Jiaotong University	Xi'an	Shanxi

Sponsors (1)

Lead Sponsor	Collaborator
ZhuHai Cardionovum Medical Device Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Target lesion restenosis determined by CTA	Restenosis defined as within the ± 5mm range beyond proximal and / or distal of target lesion, the lumen loss is greater than 50% of the reference vessel lumen diameter (RVD) follow-up by CTA.; Target lesion revascularization (TLR): clinical symptoms of peripheral arterial disease recurrence or worsening, and any target lesion re-intervention caused by diameter stenosis =50% (confirmed by Doppler ultrasound, DSA or CT angiography).	6 month post procedure
Secondary	device success rate	device success defines as: the device successfully delivered to the target location, inflated, deflated and withdrawn from the treated balloon inflation tube.	at 0-30 days
Secondary	operation success rate	operation success defines as: the blood supply of the target lesion regained after treatment, residual stenosis less than 50% and without flow-limiting dissection (=type D) occurred.	at 0-30 days
Secondary	clinical success rate	clinical success defines as: operation success, and without any postoperative complication before discharge (death, lesions limb amputation, target lesion thrombosis or TVR)	at 0-30 days
Secondary	change of the Rutherford score		in day 0-30, 6th month, 12th month post operation
Secondary	change of the life equality by EQ5D		in day 0-30, 6th month, 12th month post operation compares to baseline
Secondary	target limb ulcer healing rate	healing or not, if not: improve, no change, or progression;	in day 0-30, 6th month, 12th month post operation
Secondary	target lesion revascularization rate		in day 0-30, 6th month, 12th month post operation
Secondary	target limb upper amputation and lower amputation rate		in day 0-30, 6th month, 12th month post operation
Secondary	major adverse event rate including all cause death, target limb upper amputation and target lesion revascularization		in day 0-30, 6th month, 12th month post operation